Head of Analytical Controls
4 days ago
We are seeking a highly experienced and skilled professional to lead our Analytical Controls team as the Head of Analytical Controls. This role will be responsible for overseeing the development and implementation of analytical methods and procedures for active pharmaceutical ingredients and drug products. The ideal candidate will have a strong background in analytical development, regulatory compliance, and project management.
Key Responsibilities:
* Develop and implement analytical methods and procedures for active pharmaceutical ingredients and drug products
* Ensure compliance with regulatory requirements and industry standards
* Lead cross-functional teams to develop and implement analytical development strategies
* Collaborate with commercial functions to develop and implement strategies to control quality of drug substances and products
* Harmonize and standardize analytical processes, reporting, systems, and documents in collaboration with Quality
* Benchmark current trends within industry for all areas within Analytical Controls and strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders
* Manage complete line function responsibility for all departmental programs and initiatives
* Directs, informs, and applies outsourcing strategy for department in conjunction with senior staff and global line and function heads
Requirements:
* Bachelor degree with 20+ years of experience or advanced degree with 15+ years of relevant industry experience
* Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's
* Demonstrates effective project management skills
* GMP and compliance experience required
* Analytical method development experience required
* Regulatory submission experience required with basic knowledge for regulatory guidelines
* Global cultural awareness, manage inclusively
* Familiarity with working in a global setting
* Excellent command of English (all sites)
* People managerial experience preferred
* Team player with flexible personality but able to be persistent and assertive
* Highly reliable, self-motivated, responsible, and curious personality open to learn and develop and a pronounced desire for improvement
What We Offer:
* Competitive salary range: $205,000 - $322,300
* Eligibility for short-term and long-term incentives
* Medical, dental, vision insurance, 401(k) plan, and company match
* Short-term and long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits
* Up to 80 hours of sick time and up to 120 hours of paid vacation
EEO Statement:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.
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